Oral budesonide for maintenance treatment of collagenous colitis: a randomized, double-blind, placebo-controlled trial.
OBJECTIVE
Oral budesonide effectively induces clinical remission in patients with collagenous colitis, a debilitating illness characterized by chronic watery/loose diarrhea, but there is a high rate of relapse after treatment cessation.


METHODS
This randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of long-term therapy with oral budesonide (Entocort CIR capsules) for maintenance of clinical remission of collagenous colitis. Patients were aged >18 years with histologically proven collagenous colitis and >3 watery/loose stools per day on >or=4 of the prior 7 days. Open-label oral budesonide 9 mg/d was administered to all patients for 6 weeks. Patients in clinical remission (<or=3 stools per day) at week 6 were subsequently randomized to double-blind oral treatment with budesonide 6 mg/d or matching placebo for 6 months. Relapse was defined as >3 stools per day on >or=4 consecutive days (and included patients withdrawn because of adverse events).


RESULTS
Of 48 enrolled patients, 46 (96%) achieved clinical remission at week 6 and were randomized to maintenance budesonide or placebo. There were 21 relapses during maintenance therapy, and almost all occurred during the first 2 months. Budesonide therapy was associated with a significantly lower cumulative rate of relapse compared with placebo (6/23 [26%] and 15/23 [65%], respectively; P = .022), and high correlation between clinical remission and histologic improvement was observed. Budesonide was well tolerated with no serious adverse events.


CONCLUSIONS
Oral budesonide 6 mg/d is efficacious and well tolerated for long-term maintenance of clinical remission in patients with collagenous colitis.
Miehlke
Stephan
S
Medical Department I, Technical University Hospital, Dresden, Germany. Stephan.Miehlke@uniklinikum-dresden.de
Madisch
Ahmed
A
Bethke
Birgit
B
Morgner
Andrea
A
Kuhlisch
Eberhard
E
Henker
Christine
C
Vogel
Gerfried
G
Andersen
Matthias
M
Meier
Eberhard
E
Baretton
Gustavo
G
Stolte
Manfred
M
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001706:Biopsy; D019819:Budesonide / Q000008:administration & dosage*; D046729:Colitis, Collagenous / Q000175:diagnosis / Q000188:drug therapy*; D003113:Colonoscopy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007413:Intestinal Mucosa / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012074:Remission Induction; D012189:Retrospective Studies; D016896:Treatment Outcome
D005938:Glucocorticoids; D019819:Budesonide